Liberating the pill

Momentum gains to make oral contraceptives available over the counter

A move to make oral contraceptives available over the counter is gaining momentum in the United States - and any regulatory changes there would have significant ramifications for Canada.

Photograph by: Tim Matsui
, Getty Images

It's not addictive, it's easy to take and 50 years of use shows it's safe.

So why do women still need a prescription for the birth-control pill?

A move to make oral contraceptives available over the counter is gaining momentum in the United States - and any regulatory changes there would have significant ramifications for Canada.

Proponents for taking the pill off prescription-only status say the benefits outweigh the risks, the potential for misuse is minimal and easier access could help lower rates of unintended pregnancies and abortions.

But the prospect of women gaining unfettered access to the pill has some doctors and sexual health counsellors uneasy. Would women still see their doctor for Pap smears? Could they safely screen themselves for contraindications - conditions under which the pill should not be used? Would it unleash a marketing bonanza for drug-makers and a huge increase in users?

Nevertheless, a Canadian leader in reproductive medicine and editor of the Journal of Obstetrics and Gynaecology Canada says it seems wrong and paternalistic that, half a century after the pill's debut in the U.S. and 41 years after coming to Canada, women still cannot get access to the most effective, self-administered birth control on the market without a doctor's blessing.

Men aren't required to have a testicular or prostate exam before using condoms, Dr. Tim Rowe has argued in the pages of his own journal.

"Leaving (the pill) as a prescription-only issue does have detrimental effects on access, because there really are women who fear going to the doctor because they're going to have to have a pelvic exam, or they're going to have to have some sort of invasion of their privacy," Rowe, head of the division of reproductive endocrinology and infertility at the University of British Columbia, said in an interview.

"Men certainly wouldn't put up with that. Women put up with it as a matter of course."

Rowe says attempts to sell the pill over the counter would meet the same opposition as the human papillomavirus (HPV) vaccine that protects against the most common sexually transmitted infection in Canada. In the minds of some people, he says, the pill and the HPV vaccine only encourage promiscuity and sexual liberation.

"A sector of the population feels that's not right, that abstinence before marriage is the only acceptable thing."

But, "I think we need to explore it," he says. "We have to be cautious in every sense, but at the very least we need to have an exploration going forward about what possibly could be the harm in it?"

Thousands of women have been there: "As every woman who has run out of pills on a Sunday or forgotten to take them along on vacation knows, refills are not always easy to come by," Kelly Blanchard, president of the non-profit Ibis Reproductive Health wrote in a New York Times editorial in June.

But it's not just a matter of convenience, she said. "Women don't need a doctor to tell them whether they need the pill - they know when they are sexually active and want to avoid pregnancy. Pill instructions are easy to follow: Take one each day. There's no chance of becoming addicted. Taking too many will make you nauseated," Blanchard writes, "but won't endanger your life, in contrast to some over-the-counter drugs like analgesics."

Rowe, who, because of his editorial position, has no links, commercial or professional, to any relevant stakeholders, says the pill is "supremely efficient" in preventing pregnancy, and the number of side-effects "absolutely minimal."

Over-the-counter antihistamines that cause drowsiness during driving are potentially far more dangerous, he argues. He's convinced certain levels of safety could be injected into any over-the-counter rollout of the pill - clear instructions for use, information on side-effects and complications and reminders for women to get screened for cervical cancer - "to ensure there is no out-and-out risk."

The analogy he likes to draw is with cigarettes: "With all their health risks, why do we have cigarettes for sale whenever anyone wants them?"

Last year, Canadian retail drugs stores filled 10.3 million prescriptions for the pill, according to prescription drug-tracking firm IMS Health Canada, making oral contraceptives among the top 20 most-prescribed medications in the country. Oral contraceptives are prescribed not just for birth control, but also for abnormal bleeding and other conditions.

The pill has been one of the most studied drugs in medicine. Two years ago, a landmark study published in the British medical journal The Lancet found that the pill not only reduces the risk of ovarian cancer, the most lethal of all gynecological tumours, but that the protection lasts decades after the patient stops taking the pills.

The study's authors said the protection outweighed the increased risks of other cancers, including cancers of the breast and cervix, and that the pill that helped usher in the sexual revolution of the 1960s may already have prevented some 200,000 ovarian cancers and 100,000 deaths from the disease worldwide. The Lancet editors argued that the case for making the pill available without prescription "is now convincing.

"Women deserve the choice to obtain oral contraceptives over-the-counter, removing a huge and unnecessary barrier to a potentially powerful cancer-preventing agent," they said.

Ovarian cancer is highly lethal because symptoms are so vague, most tumours aren't detected until they're far advanced.

In Canada, the vast majority of prescriptions for the pill are for combination pills containing synthetic forms of estrogen and progesterone, a formulation that shouldn't be used by women with a history of blood clots, heart disease, migraines, liver disease and other conditions.

Because progestin-only pills carry fewer potential risks, a working group in the U.S. is looking at pursing an over-the-counter designation for that type of pill first.

There's also some precedence: Plan B, a brand of progestin-only pills approved for emergency, or "morning after", contraception, is now sold over the counter.

But if women could get the pill without a prescription, would they stop having regular gynecological exams? Studies suggest no.

Dr. Dan Grossman co-ordinates the Oral Contraceptives Over-the-Counter Working Group, a coalition of health professionals, non-profit advocacy group and university-based researchers. In a study with the University of Texas, Grossman and colleagues followed two groups of women for nine months: about 500 women living in El Paso who were crossing the border into Mexico, where pills are available without prescription, and 500 women who were getting their pills in public health clinics in El Paso.

"Even women who were getting their pills in Mexico had very high rates of getting Pap smears in the recommended frequency," says Grossman, an obstetrician/gynecologist with the Cambridge, Mass.-based Ibis Reproductive Health.

"These were often poor women who didn't have health insurance - that's why they were getting their pills in Mexico. But they were still finding a way to get their Pap smears."

The Ottawa-based Society of Obstetricians and Gynaecologists of Canada doesn't have a formal position on the issue, per se, says associate executive vice-president Dr. Vyta Senikas. "Certainly we were very much for Plan B being over-the-counter."

She said that the society's guidelines from 2004 state that, while a pelvic exam is an important part of "well-women care", it isn't a prerequisite for providing hormonal contraception.

The reality, doctors say, is that pelvic exams are being tied to the pill. Some provinces have registries in place that send out notices if a woman is overdue for a Pap, but not all.

"There's difficulty in getting women in for Pap smears, because no one likes them. There's not a lineup for Pap smears in my office," says Dr. Debbie Penava, an associate professor in the department of obstetrics and gynecology at the University of Western Ontario and director of the Women's and Children's Health Informatics Unit at the Schulich School of Medicine and Dentistry.

"What's happened over time is that people hold the birth-control prescription hostage for a Pap, which no one has wanted," Penava says. "It makes the physician seem like the bad guy or the gatekeeper."

Penava says the greatest risk with a progestin-only pill is that, if not used correctly, it's not very effective. It needs to be taken within the same two hours, every day. Progestin-only pills work in part by thinning the endometrium, the inner lining of the uterus. If not taken at the same time each day, breakthrough bleeding, or ovulation, can occur.

"It's a safe medication," Penava says. "It's just not an effective birth-control method.

"What I say to my patients is, you may as well walk around the bed three times and say a prayer."

She also said the issue of teen pregnancies is far more complex than just the availability of birth control. "Some of these teens want to be pregnant. They don't have self-esteem, they want someone to love them. That's a huge, huge societal issue."

Either way, it could take years for the pill to be sold over the counter. A spokesman for federal Health Minister Leona Aglukkaq said a manufacturer would have to make a drug submission providing evidence that the pill could safely be used in a "non-prescription" setting. Drug regulators would then have to review the data.

Still, Rowe believes it's only a matter of time before the pill is liberated.

"It's time we stopped saying these things can only ever be by prescription," he says. "I think that time has passed."

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